Aminaftone in the Treatment of Raynaud’s Phenomenon in Systemic Sclerosis: New Perspectives

Abstract

Objective: The aim of this study was to assess the efficacy (in terms of improved VAS Pain, Raynaud's Phenomenon attacks frequency and Raynaud's Condition Score) of the Aminaftone in patients with Raynaud's Phenomenon (RP) secondary to Systemic Sclerosis (SSc). Methods: Open label controlled study. We evaluated the efficacy of Aminaftone in the treatment of secondary RP in 108 patients with SSc consecutively recruited and divided in two groups. Group A: 51 Patients in treatment with Calcium Channel Blockers, prostanoids (iloprost 2ng [min/kg every 4 weeks), Endothelin Receptor Antagonist and Phosphodiesterase-5 inhibitors (Standard of Care). Group B: 57 Patients in treatment with Calcium Channel Blockers, Prostanoids, Endothelin Receptor Antagonist and Phosphodiesterase-5 inhibitors and Aminaftone (Standard of care + Aminaftone). Results: The number of RP attacks in group treated with Aminaftone (Group B) was lower than the group treated with standard therapy (Group A) from baseline to Week 48, obtaining statistically significance (Δ A-1.50 Δ B-2.10 p=0.02 95%CI). The RCS was statistically significantly different (Δ A-1.60 Δ B-2.50 p=0,04 95% CI), as was the pain VAS(Δ A-20.80 Δ B-30.60 p=0.04 95%CI) at week 48. Conclusion: The use of Aminaftone was well tolerated and improved RP as measured by RCS and pain when added to standard of care. A well-designed randomized controlled trial is needed to determine if these preliminary findings are supported.

Aminaphtone Efficacy in Primary and Secondary Raynaud’s Phenomenon: A Feasibility Study

“…Probably all these actions of aminaphtone support the first results of Parisi et al (2015) who reported the possible effectiveness of aminaphtone in association with standard therapy in RP patients, resulting in a synergic effect on vasospastic phenomena.…”

“…Aminaphtone is a synthetic derivative of 4-aminobenzoic acid (2-hydroxy-3-methyl-1,4 apthohydroquinone-2-p-aminobenzoatate), which has been used for more than 40 years in some European and South American countries in the treatment of clinical consequences of microvascular impairment (e.g., chronic venous insufficiency of the lower limbs, ulcers of legs, and microangiopathy in diabetes) (De Anna et al, 1989; Pereira de Godoy, 2010; Belczak et al, 2014; Romano et al, 2014; Martinez-Zapata et al, 2016; Felice et al, 2018). Recently, aminaphtone was reported to improve the symptoms associated with RP, as well as to reduce endothelin-1 production on cultured human endothelial cells (Scorza et al, 2008a; Parisi et al, 2015).…”

A Systematic Review of Aminaphtone from Pathophysiology to Clinical Applications: Focus on New Rheumatological Acquisitions

“…Hence, Aminaphtone has also been tested for the management of SSc-related RP. In 2015, Parisi et al enrolled 108 SSc patients, dividing them in two groups: one group was treated with the standard of care for the control of RP (calcium channel blockers, intravenous iloprost, ET receptor antagonist, and phosphodiesterase type 5 inhibitors), and the second group with the standard of care together with Aminaphtone [48]. After 48 weeks of treatment, the group of patients also treated with Aminaphtone reported a significant reduction of number of RP attacks (p = 0.02), as evaluated by Raynaud's Condition Score (RCS) and by Visual analogue scale (VAS) of pain (p = 0.04 and p = 0.04, respectively) as compared with the standard of care group, without relevant side effects [48].…”